Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.

NCT ID: NCT04682457

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-12-31

Brief Summary

The study aims is to find out if people with type 1 diabetes diagnosed in later life (after age 30) have the same rapid loss of insulin secretion (measured using C-peptide) that occurs in younger adults with type 1 diabetes. The investigators will recruit 135 participants aged over 30 years with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. The investigators will also recruit a comparison group of 61 participants aged 18-30 with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. C-peptide will be measured during mixed meal tolerance tests (MMTT) performed at baseline, 6 months and a year.

This study also aims to test a new more practical way of monitoring insulin secretion at home using a finger prick 'blood spot' rather than time consuming tests in a hospital. Finger-prick C-peptide samples will be collected after the MMTT and by the participants at home throughout the year.

Detailed Description

The study aims to evaluate progression of type 1 diabetes. Primary analysis will be conducted on those with >=1 diabetes autoantibody positive (GAD, IA2 ZNT8). Sensitivity analysis will be performed by repeating all analysis defining T1D as a) double antibody positivity and b) single antibody positivity combined with a high genetic risk score for T1D (T1DGRS>5th centile of a control population).

Further aims will be to evaluate the utility of dried blood spot testing to detect change in C-peptide and the utility of home test results as a marker of hypoglycaemia and glucose variability.

Conditions

Diabetes Mellitus, Type 1; Progression

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Late Onset

Participants diagnosed with Type 1 diabetes at over 30 years of age.

No interventions assigned to this group

18 to 30

Participants diagnosed with Type 1 diabetes between 18 and 30 years of age

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults with a clinical diagnosis of Type 1 diabetes within the previous 100 days.
• Aged >30 at the time of Type 1 diabetes diagnosis OR (additional early onset Type 1 diabetes cohort) aged ≥18 and ≤30 at the time of Type 1 diabetes diagnosis.
• Insulin treated at the time of recruitment
• Able and willing to provide informed consent.

Exclusion Criteria

• Pregnancy
• Known monogenic diabetes
• Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angus Jones, MBBS MRCP

Role: STUDY_DIRECTOR

NIHR Exeter Clinical Research Facility

Nicholas Thomas, MRCP

Role: PRINCIPAL_INVESTIGATOR

NIHR Exeter Clinical Research Facility

Locations

Royal Devon & Exeter NHS Foundation Trust

Exeter, Devon, United Kingdom

Countries

United Kingdom

References

Thomas NJ, Lynam AL, Hill AV, Weedon MN, Shields BM, Oram RA, McDonald TJ, Hattersley AT, Jones AG. Type 1 diabetes defined by severe insulin deficiency occurs after 30 years of age and is commonly treated as type 2 diabetes. Diabetologia. 2019 Jul;62(7):1167-1172. doi: 10.1007/s00125-019-4863-8. Epub 2019 Apr 10.

Reference Type: BACKGROUND

PMID: 30969375 (View on PubMed)

Other Identifiers

2003962

Identifier Type: -

Identifier Source: org_study_id